An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

(TOWER Trial)

Recruiting in Palo Alto (17 mi)

+192 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS. Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives were: * To assess the effect of the two doses of teriflunomide in comparison to placebo on: * Fatigue; * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being. * To evaluate the safety and tolerability of teriflunomide.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Inclusion Criteria

Relapsing multiple sclerosis

Two relapses in prior 2 years or one relapse in prior year.

Treatment Details

Interventions

• Placebo (Drug)
• Teriflunomide (Immunomodulator)

Participant Groups

Group I: Teriflunomide 7 mg / 14 mg Experimental Treatment 1 Intervention

Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Group II: Teriflunomide 14 mg / 14 mg Experimental Treatment 1 Intervention

Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Group III: Placebo / Teriflunomide 14 mg Placebo Group 2 Interventions

Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University